Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol (LIDA-ADJ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178642
Recruitment Status : Not yet recruiting
First Posted : November 26, 2019
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
The aim of this study is to test whether the realization of 3 courses of intra-arterial chemotherapy of idarubicin-lipiodol without embolization, administered non-selectively in the hepatic artery, following the percutaneous tumour ablation of a hepatocellular carcinoma, could constitute an effective adjuvant treatment to reduce the rates of local and intrahepatic distant recurrence and thus improve the survival without hepatic progression.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment Procedure: Percutaneous destruction of the tumor Phase 2

Detailed Description:
During this study percutaneous tumor destruction treatment with adjuvant chemotherapy (infusion of Idarubicin-Lipiodol intra-arterial hepatic) will be tested. The adjuvant chemotherapy is a minimally invasive technique. It consists of the administration of Idarubicin (Zavedos®, Pfizer) mixed with Lipiodol (Lipiodol Ultra-Fluid®, Guerbet) in the hepatic artery.The first course of treatment will be performed under general anesthesia at the same time as the percutaneous tumour ablation. The second and third cures will be performed under local anesthesia 3 and 6 weeks after percutaneous tumour ablation respectively. In the case of incomplete treatment during the percutaneous tumour ablation, the second intervention will be scheduled at the same time as the second intra-arterial chemotherapy treatment, under general anesthesia.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective multi-center phase II, randomized, unmasked comparative study (ratio 1:1), evaluating the efficacy of an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin-Lipiodol (experimental group) after percutaneous tumor ablation of hepatocellular carcinoma of size less than 3 cm, versus the absence of adjuvant treatment (standard group), on hepatic recurrence at 1 year.

It is planned to include 138 patients with hepatocellular carcinoma (CHC) less than 3 cm, non-metastatic, with cirrhosis graded A / B7 on Child Pugh scoring system, and receiving treatment by percutaneous tumor destruction.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatocellular Carcinoma Under 3 cm Treated by Percutaneous Tumor Destruction: Multicentric Phase 2 Test Evaluating the Impact of Adjuvant Chemotherapy by Intra-arterial Infusion of Idarubicin-lipiodol on the Hepatic Recurrence
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: (experimental group)
Evaluating the efficacy of an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin-Lipiodol (experimental group)
Drug: percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment
Patients will receive the standard treatment protocol consisting of a percutaneous destruction of the tumor. In addition they will receive an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin (Zavedos®, Pfizer), which is an anthracycline antineoplastic agent, mixed with Lipiodol (Lipiodol Ultra-Fluid®, Guerbet), which is a contrast agent.

Active Comparator: (standard group)
The absence of adjuvant treatment (standard group).
Procedure: Percutaneous destruction of the tumor
Patients will received the standard treatment protocol consisting of a percutaneous destruction of the tumor.




Primary Outcome Measures :
  1. The survival rate without hepatic recurrence at 1 year [ Time Frame: 1 year ]
    Hepatic recurrence will be defined as the appearance on at least one hepatic MRI with gadolinium injection of a large diameter tumor site at least greater than 10 mm, and presenting characteristics of CHC (hyper vascularization at arterial time and washing at portal or late time), either at the edge of the percutaneous tumor destruction site (= local recurrence) or at a distance from the percutaneous tumor destruction site (= intrahepatic recurrence distant), or both, after at least one liver MRI scan with gadolinium injection showed the absence of tumor residues. Lesions of more than 10 mm that do not present with the typical CHC enhancement described above will be considered CHCs if they have a growth in size of at least 1 cm on successive controls.


Secondary Outcome Measures :
  1. The incidence rate of local tumor recurrence [ Time Frame: 1 to 2 years ]
    The incidence rate of local tumor recurrence at 1 and 2 years, defined as the appearance, on at least one hepatic MRI with gadolinium injection, of a tumor site with hepatocellular carcinoma characteristics at the edge of the percutaneous tumor ablation site.

  2. The incidence rate of intrahepatic recurrence [ Time Frame: 1 to 2 years ]
    The incidence rate of intrahepatic recurrence at 1 and 2 years defined as the appearance, on at least one hepatic MRI with gadolinium injection, of a tumor site with hepatocellular carcinoma characteristics at a distance from the percutaneous tumor ablation site.

  3. The incidence rate of hepatic recurrence [ Time Frame: 2 years ]
    The incidence rate of hepatic recurrence at 2 years defined as the appearance, on at least one hepatic MRI with gadolinium injection, of a tumor site with hepatocellular carcinoma, after at least one exploration by hepatic MRI with gadolinium injection, showed the absence of tumor residue.

  4. Survival without hepatic recurrence [ Time Frame: 2 years ]
    Survival without hepatic recurrence defined as the time between the date of randomization and the date of liver MRI, having confirmed, after centralized and blind re-examination, the presence of a hepatic tumor recurrence either local or intra distant hepatic. Patients who are deceased or transplanted will be considered to have liver progression at the time of death or transplantation.

  5. Rate of survival without hepatic recurrence [ Time Frame: 1 to 2 years ]
    Rate of survival without hepatic recurrence at 1 and 2 years defined as the absence of appearance of a large diameter tumor site (at least greater than 10 mm), presenting characteristics of hepatocellular carcinoma on the border of the percutaneous tumour ablation site.

  6. Overall survival [ Time Frame: 2 years ]
    Overall survival defined as the time between the date of randomization and the date of death of the patient.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age above 18 and under 80 years-old
  • Chronic or histologically proven stage F3 or F4 hepatopathy, with liver hardness ≥ 10 kPa, or with imaging morphology suggestive of cirrhosis or portal hypertension
  • Child-Pugh score ≤ B7
  • Patients whose biological parameters meet the following criteria:

    • Platelets > 50,000 / mm3
    • Neutrophils > 1000 / mm3
    • Prothrombin ratio > 50%
    • Creatinemia < 150 μmol / L
    • Total bilirubinemia < 5 mg / dL
    • α-fetoprotein < 200 ng / mL
  • Performance level of 0 or 1 according to "World Health Organization Performance Status"
  • Presence of a single hepatocellular carcinoma of less than 3 cm with typical imaging characteristics as recommended by the American Association for the Study of Liver Diseases (AASLD)
  • Patient with an indication of percutaneous tumor ablation (radiofrequency or microwave) under ultrasound or tomodensitometric identification
  • Absence of heart failure (Left Ventricular Ejection Fraction (LVEF) > 50%)
  • Women of childbearing age, using an effective method of contraception for the duration of treatment and at least 3 months after stopping the treatment.
  • Male using an effective method of contraception throughout the treatment and at least 3 months after stopping the treatment

Exclusion Criteria:

  • Presence on the initial imaging assessment of a macroscopic vascular invasion (portal or hepatic vein)
  • Presence on initial imaging assessment of extrahepatic localization of hepatocellular carcinoma
  • Presence of another untreated cancer
  • Contraindication to performing a general anesthesia
  • Contraindication to performing an MRI scan
  • Allergy to anthracyclines, iodine or gadolinium
  • Contraindication to the injection of gadolinium-based contrast media.
  • Contraindication to iodinated contrast agents
  • Contraindication to Idarubicin (hypersensitivity to the active substance or excipients, severe heart disease, severe arrhythmia, severe renal or hepatic impairment, yellow fever vaccine or any other live attenuated vaccine for 6 months after discontinuation of chemotherapy, persistent myelosupressure, previous treatments with idarubicin and / or other anthracyclines or anthracenediones at maximum cumulative doses, mucositis, breastfeeding, uncontrolled infections, severe heart failure, myocardial infarction less than 6 months old).
  • Contraindication to Lipiodol (Hypersensitivity, Hyperthyroidism, traumatic lesions, haemorrhage or recent bleeding).
  • Patients who have already received or exceeded the recommended cumulative dose for anthracyclines (Idarubicin = 150 mg / m²).
  • Failure of endoscopic eradication of oesophageal varices of grade > 1
  • Inability to adhere to the protocol
  • Simultaneous participation to another clinical trial
  • Patients not covered by health insurance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178642


Contacts
Layout table for location contacts
Contact: Christophe CASSINOTTO 0033467339377 c-cassinotto@chu-montpellier.fr

Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Christophe CASSINOTTO University Hospital, Montpellier

Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04178642    
Other Study ID Numbers: RECHMPL19_0073
2019-001362-15 ( EudraCT Number )
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Idarubicin
Ethiodized Oil
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action